NCT01621360

Brief Summary

The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

December 19, 2011

Last Update Submit

February 6, 2013

Conditions

Femoroacetabular Impingement

Keywords

Randomized controlled trialIntention to treat

Outcome Measures

Primary Outcomes (1)

  • Hip Outcome Score (HOS)

    The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.

    24 months

Secondary Outcomes (4)

  • Non-Arthritic Hip Score

    2 weeks, and at months 3, 6, 12, 18, and 24.

  • Modified Harris Hip Score

    2 weeks, and at months 3, 6, 12, 18, and 24.

  • SF-12

    2 weeks, and at months 3, 6, 12, 18, and 24.

  • Range of Motion

    2 weeks, and at months 3, 6, 12, 18, and 24.

Study Arms (2)

Arthroscopic surgery

ACTIVE COMPARATOR

Arthroscopic surgery of the hip plus optimized medical management

Procedure: Arthroscopic hip surgery

Conservative management

ACTIVE COMPARATOR

Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.

Other: Physical therapy

Interventions

Arthroscopic hip surgeryPROCEDURE

Hip arthroscopy

Arthroscopic surgery
Physical therapyOTHER

Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.

Conservative management

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with femoroacetabular impingement of the hip
  • years of age or older
  • grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.

You may not qualify if:

  • identified isolated labral tear
  • inflammatory or post-infectious arthritis
  • previous arthroscopic treatment for hip osteoarthritis
  • previous major hip trauma
  • Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
  • patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center, University Hospital

London, Ontario, N6G 2K3, Canada

RECRUITING

Related Publications (16)

  • Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.

    PMID: 12110735BACKGROUND

  • Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.

    PMID: 18784099BACKGROUND

  • Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.

    PMID: 5054450BACKGROUND

  • Liotard JP, Cochard P, Walch G. Critical analysis of the supraspinatus outlet view: rationale for a standard scapular Y-view. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):134-9. doi: 10.1016/s1058-2746(98)90223-3.

    PMID: 9593091BACKGROUND

  • Gerber C, Terrier F, Ganz R. The role of the coracoid process in the chronic impingement syndrome. J Bone Joint Surg Br. 1985 Nov;67(5):703-8. doi: 10.1302/0301-620X.67B5.4055864.

    PMID: 4055864BACKGROUND

  • Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. doi: 10.1016/s0749-8063(99)70018-6.

    PMID: 10524832BACKGROUND

  • Thompson WO, Debski RE, Boardman ND 3rd, Taskiran E, Warner JJ, Fu FH, Woo SL. A biomechanical analysis of rotator cuff deficiency in a cadaveric model. Am J Sports Med. 1996 May-Jun;24(3):286-92. doi: 10.1177/036354659602400307.

    PMID: 8734877BACKGROUND

  • Wuelker N, Plitz W, Roetman B, Wirth CJ. Function of the supraspinatus muscle. Abduction of the humerus studied in cadavers. Acta Orthop Scand. 1994 Aug;65(4):442-6. doi: 10.3109/17453679408995490.

    PMID: 7976295BACKGROUND

  • Gosvig KK, Jacobsen S, Sonne-Holm S, Gebuhr P. The prevalence of cam-type deformity of the hip joint: a survey of 4151 subjects of the Copenhagen Osteoarthritis Study. Acta Radiol. 2008 May;49(4):436-41. doi: 10.1080/02841850801935567.

    PMID: 18415788BACKGROUND

  • Kassarjian A, Yoon LS, Belzile E, Connolly SA, Millis MB, Palmer WE. Triad of MR arthrographic findings in patients with cam-type femoroacetabular impingement. Radiology. 2005 Aug;236(2):588-92. doi: 10.1148/radiol.2362041987. Epub 2005 Jun 21.

    PMID: 15972331BACKGROUND

  • Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.

    PMID: 18560194BACKGROUND

  • Notzli HP, Wyss TF, Stoecklin CH, Schmid MR, Treiber K, Hodler J. The contour of the femoral head-neck junction as a predictor for the risk of anterior impingement. J Bone Joint Surg Br. 2002 May;84(4):556-60. doi: 10.1302/0301-620x.84b4.12014.

    PMID: 12043778BACKGROUND

  • Pfirrmann CW, Mengiardi B, Dora C, Kalberer F, Zanetti M, Hodler J. Cam and pincer femoroacetabular impingement: characteristic MR arthrographic findings in 50 patients. Radiology. 2006 Sep;240(3):778-85. doi: 10.1148/radiol.2403050767. Epub 2006 Jul 20.

    PMID: 16857978BACKGROUND

  • Peters CL, Erickson JA. Treatment of femoro-acetabular impingement with surgical dislocation and debridement in young adults. J Bone Joint Surg Am. 2006 Aug;88(8):1735-41. doi: 10.2106/JBJS.E.00514.

    PMID: 16882895BACKGROUND

  • Reynolds D, Lucas J, Klaue K. Retroversion of the acetabulum. A cause of hip pain. J Bone Joint Surg Br. 1999 Mar;81(2):281-8. doi: 10.1302/0301-620x.81b2.8291.

    PMID: 10204935BACKGROUND

  • Kim YJ, Bixby S, Mamisch TC, Clohisy JC, Carlisle JC. Imaging structural abnormalities in the hip joint: instability and impingement as a cause of osteoarthritis. Semin Musculoskelet Radiol. 2008 Dec;12(4):334-45. doi: 10.1055/s-0028-1100640. Epub 2008 Nov 18.

    PMID: 19016396BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Douglas Naudie, MD, FRCSC

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Wanlin

CONTACT

519-661-2111swanlin@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

June 18, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

CA(1)